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Apple Joins FDA Program

Apple Joins FDA Program Designed to Speed Up Approval of Health Tech

That iThingy You're Wearing
September 26, 2017

Apple is one of nine companies who has been selected for a new FDA trial that could allow health technology to be developed and approved more quickly. That’s according to a new report from Bloomberg.

Here’s more from the report about the program named Pre-Cert for Software Pilot:

The program is meant to let the companies get products pre-cleared rather than going through the agency’s standard application and approval process that can take months. Along with Apple, FitBit Inc., Samsung Electronics Co., Verily Life Sciences, Johnson & Johnson and Roche Holding AG will participate.

The FDA program is meant to help the companies more rapidly develop new products while maintaining some government oversight of technology that may be used by patients or their doctors to prevent, diagnose and treat conditions.

As part of the program, the FDA will take a close look at Apple and the other eight companies. Along with examining software, the regulatory agency will also inspect their faculties and ensure that products can be tracked on they arrive on the market.

If the FDA is satisfied with the audits, the companies would be pre-certified and have to face a less rigorous approval process or possibly none at all.

Apple has been rumored to be very interested in adding new health technology to the watch including non-invasive glucose detection.

The Apple Watch Series 3 officially landed last week but didn’t offer any new health-related features.